vitafoods b2c communication in the funtional food

B2C COMMUNICATION IN THE FUNCTIONAL FOOD

& NUTRACEUTICAL SECTOR

VitaFoodsGeneva, 11 May 2016

Karin Verzijden www.axonlawyers.com

Agenda

• Nutrition and Health Claims (Regulation 1924/2006)

• Medical claims (Directive 2001/83)

• Food Information to Consumers (Regulation 1169/2011)

• Quiz with practical examples

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Introduction Axon Lawyers

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• Amsterdam based law firm with international focus

• Fully dedicated to life sciences, familiar with food business

• Assisting high tech companies bringing innovative food products to the market

• International network through European Alliance of Life Sciences Law Firms

• Reporting current food law developments at blog FoodHealthLegal

Legal framework health and nutrition claims (1)

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Notion of “claim” is pretty broad:

• any message or representation• which is not mandatory under EU or national legislation• in any form (including text but also pictorial or symbolic messages)• that states, suggests or implies that a food has particular characteristics

Distinction between:

• nutrition claim• health claim


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Nutrition claim vs. health claim

• Nutrition claim: claim that states / implies that a food has particular beneficial nutritional properties in terms of energy and / or nutrients

“What’s in the product?”

• Health claim: claim that states / implies there is a relationship between food and health

“What does the product do?”


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General conditions for use of nutrition and health claims

• Claimed nutrient has been shown to have a beneficial nutritional or physiological effect.

• Claimed nutrient is present in the end product that will produce the claimed effect.

• Claimed nutrient is present in a form that is available to be used by the human body (“bio available”).

• The quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the claimed nutrient.


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• Nutrition claims are directed at particular nutritional effects: how much energy does a foodstuff provide and / or which nutrients does it contain?

• Currently: 30 authorized nutrition claims, subject to specific conditions of use.

Claim: High fibreProduct contains at least 6 g of fibre/100 g or at least 3 g of fibre/100 kcal. Claim: Source of proteinAt least 12% of the energy value of the food is provided by proteins.


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3 types health claims:

(1) general function claims (222+)(2) disease risk reduction claims (14)(3) Claims related to children’s development and health (11)

Ad (1) “Calcium contributes to the normal function of digestive enzymes.”

Ad (2) “Barley beta-glucans has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.”

Ad (3) “Iron contributes to normal cognitive development of children.”


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Scope Claims Regulation

Concerns use of nutrition and and health claims in all commercial communication re. food products to be delivered to final consumer

• Labelling, presentation, advertising• not applicable in exclusively scientific communication• Final consumer: distinction between regular consumer and professional?

ECJ, Case C-19/15 dated 19 January 2015 Verband Sozialer Wettbewerb / Innova Vital Gmbh

Advocate General 16 February 2016: No distinction between professional / regular consumer

Medical claims (1)

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Medical claims: claims directed at the prevention or treatment of a disease covered by Medicinal Products Directive (2001/83) and subsequent national legislation.

• Use of medical claims for food product is not allowed.

• Distinction between medicinal product / food product not always clear in cases of doubt legislation on medicinal products > any other legislation. Test applied: medicine by presentation / by function?

• Examples: krill oil and magnesium based food supplements were considered medicinal products by presentation.

• Sales perceived as marketing of medicinal product without required market authorization > sanctioned by considerable fine.

Medical claims (2)

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Food or pharmaceutical? Relevant factors according to EU case law:

(1) Characteristics of the product: form & composition (product and packaging) and pharmacological properties

• If only small quantity of API with no effect on physiological functions > no medicinal product

• Starting point: use according to prescription. Not relevant if higher dosage produces relevant physiological effect

(2) Risks implied in the use

• Forms relevant factor in product qualification, but mere risk does not render product automatically a medicinal product

• “Upper safe levels” (art. 5.a Directive 2002/46) does not play decisive role in qualification

Medical claims (3)

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Landmark case European Court of Justice: van Bennekom (227/82)> Defines dividing line between medicinal products and food

Facts• Large quantity of (multi) vitamin preparations traded by Dutch national

van Bennekom was seized > contrary to Medicinal Products Supply Act.• Preparations in pharmaceutical form and highly concentrated.• Van Bennekom did not meet registrations & authorization requirements.• According to him, products were foodstuffs, not medicinal products.

Ruling• Concept of “presentation” broadly construed > consumer protection.• No benchmark for vitamins to qualify as a medicinal product > evaluation

on case-by-case basis.• Under certain circumstances, MS may stop imports of products at stake.

Medical claims (4)

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District Court Rotterdam 14 March 2014: fine of > € 30K for marketing of food supplements containing vitamin D, Krill oil and magnesium

• Information provided on the benefits of the supplements led the authorities to believe that product qualified as medicinal product by presentation.

• Criterion broadly interpreted for protection of public health.

Learning: in the Netherlands DDR-claims that deviate from authorized wording quickly qualify as medical claims.

Medical claims (5)

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Medical claims: What are the possibilities re. health products?

• Grey area between medical claims / nutrition and health claims• Useful tool Dutch self-regulatory body: Indicative List Health

Recommendation accessible by keyword and indication• Similar initiatives in other EU Member States

Food information (1)

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On 13 December 2014: Entry into force of Regulation 1169/2001 re. Food Information to Consumers. New elements in comparison to previous legislation:

• Additional requirements re. list of ingredients and language requirements;

• Detailed requirements re. legibility;

• Nutrition declaration compulsory as of 13 December 2016. However, when health claims are used, nutrition declaration must also be applied.

Also explicit prohibition that food information shall not attribute to any food the property of preventing, treating or curing a human disease.


Language requirements• Mandatory information should be in a language that is easily understood

by the consumer of the MS where product is marketed.• MS may stipulate that mandatory information is in one or more of the

official EU languages re. food products marketed in their territory.

List of ingredients• Heading “ingredients” followed by list of ingredients in descending order

of weight;• Ingredients that may cause allergies/intolerances should be emphasised

through a specific type set; • QUID when ingredient is contained in name of the product

or otherwise emphasized to characterize the product.

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List of ingredients in relation to pictures on product packaging

ECJ, case C-195/14, 4 June 2015Verbraucherzentrale Bundesverband e.V. v Teekanne GmbH & Co. KG

• German Company Teekanne marketed a fruit tea called Felix raspberry and vanilla adventure.

• Packaging contained pictures of raspberry and vanilla, but none of these ingredients were specified in the list of ingredients.

• ECJ: even if list of ingredients is correct, it cannot be excluded that consumer will be misled.


Legibility

Where should mandatory food information be mentioned? • Pre-packed food products: directly on the package or on the label

attached thereto;• Non pre-packed food products: MS can take national measures re.

communication of materials causing allergens/intolerances.

How should the mandatory information be shaped?• Easily visible and clearly legible;• Minimum font size1.2 mm or 0.9 mm when packaging < 80 cm2.

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Nutrition declaration

Energy value and nutrients:• relate to the food as sold or after preparation, provided that sufficiently

clear instructions for preparation are provided;• are expressed per 100 g or 100 ml;• only in addition thereto expression per portion / consumption unit

provided that portion is quantified and number of portions mentioned.

Presentation:• in tabular format (if space does not permit: in linear format);• different forms of expression permitted when supported by wide range

of stake holders and not misleading for the consumer.

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Quiz (1)

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Do these pictures contain nutrition and/or health claims?If so, what type of claims?

Quiz (2)

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And how about this logo?

Quiz (3)

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How do you assess this health claim: authorized / not authorized?

“Compound X is a bioactive protein supporting healthy aging”

Quiz (4)

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What type of claims can be made for these types of products, if any?

Quiz (5)

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” What health claim for FruitFlow?

• DSM was one of the first companies to obtain authorization for a 13.5 health claim re. positive effect van lycopene extracted from tomato's.

• Product Fruitflow is offered in powder and in liquid format.

• Active dose: 3 g / 250 ml drink or 150 mg / daily dose or portion.

Quiz (6)

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• Claim # 1: “helps to maintain a healthy blood flow and benefits circulation”.

• Claim # 2 “Helps maintain normal platelet aggregation, which contributes to a normal bloodflow”.

• Claim # 3: “Fruitflow as a natural alternative to Aspirin”.

Which one do you think was granted?

Conclusion

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• Distinguish between mandatory and voluntary information in B2C communication re. functional food & nutraceuticals; make sure that mandatory information complies with applicable legal framework.

• When using voluntary information: expressions quickly qualify as a nutrition or health claim. Know the rules!

• Only use authorized claims in B2C communication and avoid medical claims in combination with food products.

Karin Verzijden [email protected] Advocaten www.axonadvocaten.nl

mailto:[email protected]

http://www.axonadvocaten.nl/